‘Precedents are important’: Aduhelm coverage restrictions could shape the future of accelerated approval

Whither accelerated approval?

Amid the hubbub over new Medicare coverage restrictions for Alzheimer’s treatments, a key issue may not be fully appreciated: There is now bona fide pushback against accelerated approval, a controversial strategy used by regulators and companies to get new drugs to market faster than usual.

On its face, this suggests potentially wider — and sobering — implications for the pharmaceutical industry and patients, because they may one day have to wait longer for new medicines to get out the proverbial door.

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